MAUDE Adverse Event Report: HILL-ROM BATESVILLE ENVISION BLOWER KIT; BED FLOATATION THERAPY POWERED

Model Number P136026

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the alarm not working.Per the hillrom user manual warning: the bed exit alarm is a local alarm only.It is not connected to the facility¿s nurse call system.The bed exit alarm is a local alarm only.It is not connected to the facility¿s nurse call system.There are two settings for the bed exit alarm: patient movement and out of bed.The patient movement alarm will sound when the patient moves away from the head section, such as sitting up in bed.The out of bed alarm will sound when the patient¿s presence is no longer detected on the surface.To engage either alarm, press the applicable alarm control.When the alarm is engaged, the icon for alarm will show on the main screen.When the alarm sounds, a message screen will show on the main screen.Follow the instructions on the screen.If the alarm is silenced but not reset, after 15 minutes, the alarm will sound again.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in jun 2019.It is unknown if the facility performed any other preventative maintenance on this bed.The technician turned the bed off and on and re-entered the patients weight to resolve the issue.Based on this information, no further action is required.

Event Description

Hillrom received a report from the account stating the bed had no alarms.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: ENVISION BLOWER KIT
• Type of Device: BED FLOATATION THERAPY POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: beth graceffa ; 1069 state route 46 east; batesville, IN 47006 ; 3122337700
• MDR Report Key: 9709923
• MDR Text Key: 192224951
• Report Number: 1824206-2020-00076
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P136026
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1